JP6416091B2 - Microwave ablation catheter and method of using the same - Google Patents

Microwave ablation catheter and method of using the same Download PDF

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JP6416091B2
JP6416091B2 JP2015526564A JP2015526564A JP6416091B2 JP 6416091 B2 JP6416091 B2 JP 6416091B2 JP 2015526564 A JP2015526564 A JP 2015526564A JP 2015526564 A JP2015526564 A JP 2015526564A JP 6416091 B2 JP6416091 B2 JP 6416091B2
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working channel
microwave ablation
elongate working
ablation catheter
configured
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JP2015524704A (en
Inventor
エム. ラトカウ,ケーシー
エム. ラトカウ,ケーシー
ブラナン,ジョゼフ,ディー.
ピーターソン,ダリオン,アール.
ラーソン,エリック,ダブリュー.
ヘイリー,ケイレン
ディックハンズ,ウィリアム,ジェイ.
ケイス,ジェイソン,エー.
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コビディエン エルピー
コビディエン エルピー
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Priority to US61/680,555 priority
Priority to US61/784,407 priority
Priority to US61/784,297 priority
Priority to US201361784297P priority
Priority to US201361784048P priority
Priority to US201361784176P priority
Priority to US201361784407P priority
Priority to US201361783921P priority
Priority to US61/783,921 priority
Priority to US61/784,048 priority
Priority to US61/784,176 priority
Priority to PCT/US2013/052187 priority patent/WO2014025551A1/en
Application filed by コビディエン エルピー, コビディエン エルピー filed Critical コビディエン エルピー
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    • A61B1/018Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
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    • A61B2018/1861Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves with an instrument inserted into a body lumen or cavity, e.g. a catheter
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    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
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Description

(Cross-reference of related applications)
This application is filed with US Provisional Patent Application No. 61 / 680,555, filed Aug. 7, 2012 by Brannan et al., US Provisional Patent Application No. 61/783, filed Mar. 14, 2013 with Ladtkow et al. No. 921, U.S. Provisional Patent Application No. 61 / 784,048 filed Mar. 14, 2013 by Ladtkow et al. No. 176, US Provisional Patent Application No. 61 / 784,297, filed March 14, 2013 by Ladtkow et al., And US Provisional Patent Application No. 61/784, filed Mar. 14, 2013 by Ladtkow et al. , 407, the benefit and priority of which are hereby incorporated by reference in their entirety. It is incorporated seen.

  The present disclosure relates to microwave ablation catheters and methods of using the same. More particularly, the present disclosure relates to a microwave ablation catheter that can be placed through one or more branch lumen networks of a patient to treat tissue.

  Microwave ablation can be used to treat various diseases such as nodules in different organs such as the liver, brain, heart, lungs and kidneys. For example, if a nodule is found in the lung, several factors are considered when making the diagnosis. For example, biopsy tissue of nodules may be collected using a biopsy instrument under CT guidance. If biopsy reveals that the nodule is malignant, it may be useful to cauterize the nodule. In this case, the nodules can be cauterized using microwave ablation, which typically involves transmitting microwave energy to the percutaneous needle. Under certain surgical conditions, certain current percutaneous methods of microwave ablation can cause pneumothorax (air leaks), collecting air in the space around the lungs, which clinicians notice If not, the lung or part of it may eventually be collapsed.

  Intrabronchial navigation uses CT image data to create a navigation plan and facilitates advancing the navigation catheter (or other suitable device) through the bronchoscope and the bifurcation of the patient's bronchi to the nodule . Also, electromagnetic tracking may be used with CT data to facilitate guiding the navigation catheter through the bronchial bifurcation to a nodule. In some cases, a navigation catheter may be placed in one of the airways of the branch lumen network adjacent to or within the nodule or location of interest to provide access for one or more instruments. Good. Once the navigation catheter is in place, fluoroscopy is used to move biopsy instruments, such as biopsy brushes, needle brushes, and biopsy forceps, through the navigation catheter to a nodule or destination in the lung. May be visualized.

  As can be appreciated, a microwave ablation catheter that can be placed through one or more branch lumen networks of a patient to treat tissue may be useful in an operating room.

  Aspects of the present disclosure will be described in detail with reference to the drawings. In the drawings, like numerals refer to like or identical elements. As used herein, the term “distal” refers to the portion that is said to be farther from the user, and the term “proximal” refers to the portion that is said to be closer to the user.

  Aspects of the present disclosure provide a microwave ablation system configured for use in a luminal network. The microwave ablation system includes a microwave energy source and an instrument for treating tissue. The elongate working channel is configured to provide a passage for the instrument. A positionable guide movable through the elongate working channel is configured to navigate the elongate working channel until it is adjacent to the target. The microwave ablation system may include a bronchoscope configured to receive an elongate working channel to provide access to the luminal network.

  The instrument may be a microwave ablation catheter. The microwave ablation catheter may comprise a coaxial cable connected at its proximal end to a microwave energy source and connected at its distal end to a distal radiant section. A coaxial cable includes inner and outer conductors and a dielectric positioned therebetween. The inner conductor extends distally beyond the outer conductor and is in sealing engagement with the distal radiating portion. The balun is partially formed of a conductor that is electrically connected to the outer conductor of the coaxial cable, and extends along at least a portion of the coaxial cable. The conductor has a braided configuration and is covered with at least one insulator.

  The elongate working channel may have a closed distal end and a multi-lumen configuration configured to receive an ablation catheter. The elongate working channel may further comprise a hub at its proximal end. The hub may include a fluid intake port and a fluid return port configured to allow coolant to flow in and out of the elongate working channel to cool the ablation catheter, respectively.

  An expandable member may be provided on the outer surface of the extensible working channel. The expandable member is movable in an inflated state so as to form an embolus when the microwave ablation catheter is placed in the luminal network. The expandable member may be configured to control local characteristics of the luminal network. The expandable member secures the elongate working channel when the elongate working channel is placed in the lumen network, and the elongate working channel is moved as the positionable guide or the present microwave ablation catheter moves through it. It may be configured to prevent from moving out of place. The expandable member may be in the form of a balloon.

  Alternatively, the balun may be movable in an expanded state so as to form an embolus when the present microwave ablation catheter is placed in the luminal network. The balun may be configured to fix the microwave ablation catheter when the microwave ablation catheter is placed in the lumen network and maintain the microwave ablation catheter in a relatively fixed configuration. Good.

  The distal radiant portion of the present microwave ablation catheter or the distal tip of the elongate working channel may be selectively energized to penetrate tissue. Further, the distal radiating portion of the present microwave ablation catheter may be covered with a temperature sensitive wax that is configured to melt when the present microwave ablation catheter is activated. Further, the piston including the needle may be operably coupled to at least one fluid port of the elongate working channel and extendable from the distal end of the elongate working channel to puncture tissue.

  The distal end of the elongate working channel may be energizable to penetrate the target tissue. The distal end of the extensible working channel may comprise one or more electrodes that extend at least partially along the outer peripheral surface of the extensible working channel. The electrode may be operable in a monopolar mode of operation.

  The microwave ablation system may include a navigation system configured to follow a predetermined determined path to guide an instrument, an elongate working channel or a positionable guide through the luminal network. The predetermined path may be generated based on computed tomography (CT) data of the luminal network or displayed in the generated model. A predetermined route may be generated from the CT data to identify the route to the target identified by the user in the CT data, and this route to obtain user consent prior to use in the navigation system. May be generated. The navigation system may include a head-up display device.

  Hereinafter, various embodiments of the present disclosure will be described with reference to the drawings.

1 is a perspective view of a microwave ablation system comprising a microwave ablation catheter assembly configured for use in a microwave ablation system according to an embodiment of the present disclosure. FIG. FIG. 3 is a front view of one embodiment of a lumen configuration configured for use with the microwave catheter assembly shown in FIG. 1. FIG. 6 is a front view of another embodiment of a lumen configuration configured for use with the microwave catheter assembly shown in FIG. 1. FIG. 6 is a front view of another embodiment of a lumen configuration configured for use with the microwave catheter assembly shown in FIG. 1. Another implementation of a lumen configuration configured for use with the microwave catheter assembly shown in FIG. 1, wherein the lumen supporting the coaxial microwave structure also communicates with the cooling fluid inflow or outflow port. It is a front view of a form. 2 is a perspective view of the distal end of a microwave ablation catheter configured for use with the microwave ablation assembly shown in FIG. FIG. 5 is a cross-sectional view taken along line 5-5 of FIG. 4 is a screenshot of a CT-based lumen navigation system according to one embodiment of the present disclosure. FIG. 3 is a perspective view of a microwave ablation system and lumen navigation system configured for use with the microwave ablation catheter assembly shown in FIG. 1 and the microwave ablation catheter shown in FIG. 2 according to one embodiment of the present disclosure. 1 is a side view of a luminal catheter delivery assembly with an extensible working channel and a positionable guide catheter according to an embodiment of the present disclosure. FIG. FIG. 9 is a partial perspective view of the distal end of the positionable guide catheter shown in FIG. 8. FIG. 9 is a side view of the elongate working channel shown in FIG. 8 with a microwave ablation catheter extending from its distal end. 4 is a screenshot of a CT-based lumen navigation system according to one embodiment of the present disclosure. FIG. 3 is a schematic plan view of an elongate working channel placed in a bronchoscope before being placed in a patient's trachea. FIG. 12B is a schematic plan view of the bronchoscope shown in FIG. 12A positioned in the trachea of a patient with an extendable working channel extending distally therefrom. FIG. 6 is a partial cutaway view of an elongate working channel and a positionable guide disposed within a bronchoscope. FIG. 6 is a schematic plan view of a bronchoscope positioned in a patient's trachea with an extendable working channel extending distally therefrom. FIG. 6 is a partial cutaway view of an elongate working channel and biopsy instrument placed in a bronchoscope. FIG. 3 is a schematic plan view of a bronchoscope placed in a patient's trachea with an extendable working channel removed from the bronchoscope. FIG. 6 is a schematic plan view of a bronchoscope placed in a patient's trachea with an elongate working channel extending distally therefrom according to another embodiment. FIG. 15B is a partial cutaway view of the elongate working channel shown in FIG. 15A positioned in the bronchoscope. FIG. 15B is a schematic plan view of a bronchoscope placed in the trachea of a patient with the elongate working channel shown in FIG. 15A extending distally therefrom. FIG. 15B is a schematic plan view of a bronchoscope with the elongate working channel shown in FIG. 15A extending distally therefrom and positioned within the patient's trachea adjacent to the target tissue. FIG. 3 is a partial cutaway view of the elongate working channel and microwave ablation catheter shown in FIG. 2 connected to each other and placed in a bronchoscope. It is sectional drawing which followed the 16D-16D line | wire of FIG. 16C. FIG. 15B is a schematic plan view of another embodiment of the elongate working channel shown in FIGS. 9 and 15A having a balloon disposed in the patient's lung and coupled thereto in a deflated configuration. FIG. 18 is an enlarged region of detail of FIG. 17 showing the balloon in an inflated configuration. FIG. 4 is a schematic plan view of another embodiment of a balun configured for use with the microwave ablation catheter shown in FIG. 2 shown in an expanded configuration. FIG. 19B is a schematic plan view of the balun shown in FIG. 19A in a non-expanded configuration. FIG. 15B is a schematic plan view of a distal tip configuration that can be utilized with the microwave ablation catheter assembly shown in FIG. 1, the microwave ablation catheter shown in FIG. 2, or the elongate working channel shown in FIG. 15A. FIG. 15B is a schematic plan view of another embodiment of the extendable working channel shown in FIG. 15A. FIG. 15B is a schematic plan view of yet another embodiment of the extendable working channel shown in FIG. 15A. FIG. 8 is a perspective view of another embodiment of the lumen navigation system shown in FIG. 7. FIG. 6 is a partial cutaway view of another embodiment of the microwave ablation catheter shown in FIG. 1. FIG. 25 is a cross-sectional view taken along line 25-25 in FIG. 24. FIG. 25 is a cross-sectional view taken along line 26-26 in FIG. 24. FIG. 6 is a partial cutaway view of yet another embodiment of the microwave ablation catheter shown in FIG. 1. FIG. 6 is a schematic plan view of yet another embodiment of the microwave ablation catheter shown in FIG. 1. FIG. 29 is a schematic plan view showing a circulatory feedback loop configured for use with the elongate working channel shown in FIGS. 15A, 17 and 21 and the microwave ablation catheter shown in FIGS. 1, 24 and 27-28. . FIG. 15B is a schematic plan view of yet another embodiment of the elongate working channel shown in FIG. 15A. FIG. 15B is a schematic plan view of yet another embodiment of the elongate working channel shown in FIG. 15A including the microwave ablation catheter shown in FIG. 2 in a collapsed configuration. FIG. 32 is a schematic plan view of the elongate working channel shown in FIG. 31 including a microwave ablation catheter shown in an extended configuration. FIG. 15B is a schematic plan view of yet another embodiment of the elongate working channel shown in FIG. 15A. FIG. 15B is a schematic plan view of yet another embodiment of the elongate working channel shown in FIG. 15A shown in a non-expanded configuration. FIG. 35 is a schematic plan view of the extendable work channel shown in FIG. 34 in an expanded configuration. 3 is a front view of another embodiment of the microwave ablation catheter shown in FIG. 2 including a thermally conductive balloon coupled thereto and shown in a contracted configuration. FIG. FIG. 36B is a front view of the microwave catheter shown in FIG. 36A including a thermally conductive balloon shown in an expanded configuration. FIG. 3 is a front view of another embodiment of the microwave ablation catheter shown in FIG. 2 including a plurality of thermally conductive fins coupled thereto and shown in an undeployed configuration. FIG. 37B is a front view of the microwave catheter shown in FIG. 37A including a plurality of thermally conductive fins shown in a deployed configuration. FIG. 15B is a schematic plan view of yet another embodiment of the elongate working channel shown in FIG. 15A. FIG. 3 is a schematic plan view of another embodiment of the microwave ablation catheter shown in FIG. 2 including a balloon coupled thereto and shown in a deflated configuration. FIG. 39B is a schematic plan view of the microwave catheter shown in FIG. 39A including a balloon shown in an expanded configuration. FIG. 8 is a schematic plan view of various fiducial markers configured for use in the microwave ablation system shown in FIG. 7 shown adjacent to a non-cauterized target tissue. FIG. 40B is a schematic plan view of the fiducial marker shown in FIG. 40A shown adjacent to the ablated target tissue. FIG. 8 is a schematic plan view of a guide wire including a plurality of thermocouples configured for use in the microwave ablation system shown in FIG. 7. FIG. 8 is a perspective view of an electrical measurement system configured for use with the microwave ablation system shown in FIG. 7. FIG. 8 is a schematic plan view of a feedback configuration configured for use with the microwave ablation system shown in FIG. 7. FIG. 8 is a schematic plan view of another embodiment of a feedback configuration configured for use with the microwave ablation system shown in FIG. 7. FIG. 8 is a schematic plan view of yet another embodiment of a feedback configuration configured for use with the microwave ablation system shown in FIG. 7. It is a fluoroscopic image of a patient in which a catheter is disposed in the body. It is a virtual fluoroscopic image of a patient showing a target.

  Although detailed embodiments of the present disclosure are disclosed herein, the disclosed embodiments are merely examples of the present disclosure and may be implemented in various forms. Accordingly, the specific structural and functional details disclosed herein are not to be construed as limiting the present invention, but merely serve as the basis for the claims and the disclosure to those skilled in the art. Should be construed as a representative basis for teaching the various uses for any reasonably detailed structure.

  As can be appreciated, an energy device such as a microwave ablation catheter that can be placed through one or more branch lumen networks of a patient to treat tissue can be useful in an operating room and the present disclosure is Apparatus, system and method. Access to the luminal network may be percutaneous or from a natural opening. In the case of natural openings, endobronchial methods can be particularly useful in the treatment of pulmonary diseases. A combination of diagnostic imaging and / or planning software may be used to plan targets, navigation, access and treatment pre-operatively. According to these aspects of the present disclosure, the planning software may obtain custom guidance using preoperative images. Lumen network navigation may be accomplished using image guidance. These image guidance systems may be separate or integrated with energy devices or separate access devices, including MRI, CT, fluoroscopy, ultrasound, electrical impedance tomography, optical devices and device tracking systems. Can be mentioned. Positioning methods for separate devices or devices integrated into energy devices or separate access devices include EM, IR, echolocation, optical devices, and the like. The tracking system may be integrated into the diagnostic imaging device, where tracking is performed in a virtual space or fused with pre-operative or live images. In some cases, the treatment target may be accessed directly from within the lumen, such as for treatment of the inner bronchial wall for chronic obstructive pulmonary disease (COPD), asthma, lung cancer, and the like. In other cases, the energy device and / or additional access device is required to puncture the lumen, such as for treatment of a disease within the parenchyma, and extend into other tissues to reach the target Sometimes it becomes. Final location and confirmation of energy device placement may be performed by diagnostic imaging and / or navigation guidance using the medical imaging devices listed above. The energy device has the ability to deliver a therapeutic energy field (including but not limited to an electromagnetic field) and may have the ability to monitor treatment during energy irradiation. Treatment monitoring includes temperature measurement, electrical impedance, radiation measurement, density measurement, light absorption, hydration, ultrasound, and the like. Additionally or alternatively, additional devices or the above image guidance device may be used to monitor treatment from within the lumen or from outside the body. After treatment, the energy device and / or further device may have the ability to verify that an appropriate treatment has been performed using at least the techniques described above for treatment monitoring. Furthermore, treatment confirmation may be from within the lumen or from outside the body. Long-term therapeutic actions may be performed with diagnostic imaging that can be integrated into the follow-up software application.

  One embodiment of the present disclosure relates, in part, to a microwave ablation catheter that can be placed through one or more branch lumen networks of a patient to treat tissue. The microwave ablation catheter is part of an ablation system that includes a microwave energy source and a planning and navigation system for placing the catheter at a desired location within the lumen network. The system further includes a medical diagnostic imaging apparatus that can be used to confirm the placement of the catheter and the effects of energy irradiation. The microwave catheter itself may be equipped with the ability to assist in confirming placement within the treated tissue, or additional devices may be used in combination with the microwave catheter to place within the treated tissue. May be confirmed. Still further, one or more thermocouples or temperature sensors on the microwave catheter detect the temperature of the microwave catheter or the tissue surrounding the catheter for safety and for dosage and treatment patterns. For monitoring, it is possible to monitor the microwave catheter temperature and tissue temperature during and after treatment. The microwave catheter may also assist access to the target tissue from either the lumen or the lumen. In addition to support by other monitoring and confirmation devices, the present microwave catheter may support treatment monitoring by various measurement techniques and may be used for treatment confirmation.

  1 to 5 show various aspects of a microwave ablation system 10 (system 10). The system 10 shown in FIG. 1 includes a microwave ablation catheter assembly 12 (assembly 12) configured to receive a microwave ablation catheter 14 (cautery catheter 14) (shown in FIG. 4). The assembly 12 and the ablation catheter 14 are configured to connect to a microwave energy source (energy source 16) that is configured to transmit microwave energy to the catheter 14 to treat a target tissue (eg, lung tissue). Has been.

  The assembly 12 shown in FIG. 1 provides a path for a cooling medium that circulates in the assembly 12 that receives the ablation catheter 14 and cools the ablation catheter 14 when energy is supplied to the ablation catheter 14. It is configured. With these objectives in mind, the assembly 12 has an outer sheath 18 (FIG. 2) and a plurality of lumens 19a, 19b and 19c extending from the proximal end 20 to the distal end 22, and It is formed of overmolded plastic to form a generally elongated housing 23 that includes a distal tip 21 that is relatively pointed or appropriately rounded. Hub portion 24 is provided at proximal end 20 and includes ports 26a, 26b, 26c that connect to corresponding distal ends (not explicitly shown) of connecting tubes 28a, 28b, 28c. The connecting tubes 28a, 28c are either directly or directly to a fluid source 32 with hoses 31a, 31b that supply one or more suitable cooling media (eg, water, saline, air, or combinations thereof) to the ablation catheter 14. Each proximal end 30a, 30c is configured to be indirectly removably connected. In an embodiment, the fluid source 32 is a cooling device as disclosed in US Patent Application No. XX / XXX, XXX of Attorney Docket No. H-IL-00083, the entire disclosure of which is incorporated herein by reference. It may be a component of the system. The proximal end 30 b of the connecting tube 28 b is configured to connect directly or indirectly to the energy source 16 for supplying energy to the ablation catheter 14. Any pair of wings 34 a, 34 b may be provided at the proximal end 20 of the assembly 12. The wings 34a, 34b may extend laterally from each of the right and left sides of the proximal end 20, and may be placed on the patient's body or grasped by the clinician for operation of the assembly 12. It may be configured.

  Ports 26a, 26c of assembly 12 are in fluid communication with corresponding lumens 19a, 19c of a plurality of lumens 18 provided in assembly 12 (FIG. 2), and one of the cooling media of assembly 12 is It is configured to supply seeds. In one embodiment, such as the embodiment shown in FIG. 2, port 26a is an outflow port, providing an outflow point from the outflow lumen 19a of the cooling medium, and port 26c is an inflow port, in the inflow of the cooling medium. Provides an entry point into the cavity 19c.

  FIG. 3A shows another lumen configuration that can be utilized with assembly 12. In this embodiment, two outflow lumens 19a 'and one inflow lumen 19c' are provided and are in fluid communication with the respective ports 26a, 26c.

  FIG. 3B illustrates another lumen configuration that can be utilized with assembly 12. In this embodiment, two outflow lumens 19a 'and one inflow lumen 19c' are provided and are in fluid communication with the respective ports 26a, 26c. In addition, a lumen that supports a coaxial microwave structure is also used for either inflow or outflow of fluid.

  FIG. 3C shows another lumen configuration similar to FIGS. 3a and 3b that can be utilized with the assembly 12. In this embodiment, two outflow lumens 19a 'and two inflow lumens 19c' are provided and are in fluid communication with the respective ports 26a, 26c.

  A third lumen 19b is provided in the assembly 12 and is configured to support the ablation catheter 14 when the ablation catheter 14 is connected to the assembly 12. In the embodiment shown in FIG. 2, the outflow lumen 19a and the inflow lumen 19c are formed on the lumen 19b. In the embodiment shown in FIG. 3A, the lumen 19b includes an outflow lumen 19a and an inflow lumen 19c to provide two opposing outflow lumens 19a and two opposing inflow lumens 19c around the lumen 19b. Located in the middle between. In the embodiment shown in FIGS. 3A and 3B, the lumen 19b is connected to the outflow lumen 19a and the inflow lumen to provide two opposing outflow lumens 19a and one opposing inflow lumen 19c around the lumen 19b. It arrange | positions in the center between the cavity 19c. The lumen configuration shown in FIGS. 2 and 3A-3C provides the assembly 12 with the necessary flexibility to move through the relatively thin guide bronchi (and / or blood vessels) at the bronchial bifurcation.

  In one embodiment, assembly 12 may comprise a four lumen configuration (not shown). In this embodiment, the three outer lumens (eg, a combination of outflow lumen 19a and inflow lumen 19c) are configured to support the ablation catheter 14 when the ablation catheter 14 is connected to the assembly 12. It may be arranged around the central lumen (for example, the lumen 19b) at equal intervals. In one particular embodiment, the three outer lumens may be configured to include two inflow lumens 19c and one outflow lumen 19a (and vice versa).

  Outflow lumen 19a and inflow lumen 19c extend a predetermined distance within assembly 12 and can function with various coolant feedback protocols (eg, open or closed feedback protocols). In the embodiment shown in FIGS. 2 and 3A-3C, the inflow lumen 19c extends distal to the outflow lumen 19a so that an appropriate amount of cooling medium can be circulated around the ablation catheter 14. doing. Of course, regardless of the number or configuration of the lumens, the unfilled space in the lumen supporting the coaxial cable and the radiating portion can be used for further fluid entry or discharge to allow fluid flow. The coaxial microwave structure may be directly cooled by improving the flow and by close fluid contact. Lumen 19b may not only support the ablation catheter, but may also support further outflow or inflow of coolant, thereby connecting lumen 19b to connecting tubes 28a, 28c and their respective proximal ends 30a. , 30c may be connected.

  4 and 5, an ablation catheter 14 is shown. The ablation catheter 14 includes a coaxial cable 36. The coaxial cable 36 includes a proximal end 38 that connects to an inner conductor 40 and outer conductor 48 of the coaxial cable 36 and a port 26b (shown in FIG. 1) that provides electrical connection to the energy source 16.

  As best shown in FIG. 5, a distal radiating portion 42 is provided at the distal end 44 of the coaxial cable 36 and is configured to receive the inner conductor 40. The distal radiating portion 42 may be formed of any suitable material. In an embodiment, the distal radiating portion 42 may be formed of ceramic or metal (eg, copper, gold, silver, etc.). The distal radiating portion 42 may comprise any suitable configuration such as, but not limited to, a blunt configuration, a flat configuration, a hemispherical configuration, a pointed configuration, a barbell configuration, a tissue puncture configuration, and the like. . The distal radiating portion 42 may be coupled to the distal end 44 of the coaxial cable by soldering, ultrasonic welding, adhesive, or the like. In one embodiment, the distal radiating portion 42 is sealed against the inner conductor 40 and the dielectric 50 to prevent fluid from contacting the inner conductor 40. Alternatively, the seal may be just between the inner conductor 40 and the dielectric 50.

  The outer conductor 48 is braided and extends along the dielectric 50 located between the inner conductor 40 and the outer conductor 48 (FIG. 5). The braid defined in this specification means a braid produced by intertwining three or more strands, and it is expressed as a braid. However, the actual configuration is not so limited, and As will be appreciated by those skilled in the art, other formations of the outer conductor of the coaxial cable may be included. One advantage of the braided configuration of the outer conductor 48 is that it provides the ablation catheter 14 with the flexibility to move within a relatively narrow lumen structure, such as a patient's lung airway. In addition, the cross-sectional dimensions of the braided conductors were stretched while maintaining acceptable electrical performance through the use of a braided compression with a flat wire braid and subsequent appropriately sized mold. Compared to other conductive structures such as copper tubes, it can be remarkably minimized.

  A choke or balun 52 is partially formed with a conductive layer 51 extending along a portion of the coaxial cable 36. The conductive layer 51 may be a netting material having the same configuration as that of the outer conductor 48, and is connected to the outer conductor 48. Specifically, a portion of the outer conductor 48 is shorted to the proximal portion 54 of the conductive layer 51 (eg, soldered, interwoven, or otherwise affixed). Is).

  The balun 52 includes the insulating layer 56 and may be formed of polytetrafluoroethylene (PTFE). The insulating layer 56 is generally formed between the conductor 52 and the outer conductor 48. The insulating layer 56 extends distally beyond the distal end of the conductor 52. The insulating layer 56 extending beyond the conductive layer and its orientation can be adjusted during manufacture to control the overall phase, energy field profile, and temperature response of the coaxial cable 36.

  The outer conductor 48 extends distally beyond the insulating layer 56. A portion of the outer conductor 48 is removed to expose the dielectric 50 of the coaxial cable 36 to form a feed gap 58. Feed gap 58 is distal from balun 52 and is located immediately adjacent to and proximal from distal radiating portion 42. Feed gap 58 and distal radiating portion 42 are positioned and dimensioned to achieve a specific radiation pattern for ablation catheter 14.

  The ablation catheter 14 may optionally include an outer sheath 62 that extends to the proximal end 54 of the balun 52. Alternatively, the insulating layer 56 extends beyond the conductive layer 51 of the balun 52 using only a thin layer of insulator 60 (eg, a layer of polyethylene terephthalate (PET)) without the outer sheath 62. Part of the outer conductor 48 and the balun 52 may be covered up to the place (FIG. 5). In a still further embodiment, the layer of PET 60 is configured to extend proximally along the length of the coaxial cable 36 to help maintain the braided configuration of the outer conductor 48 and the conductive layer 51. It may be. As will be appreciated by those skilled in the art, the flexibility of the ablation catheter 14 is achieved by removing the outer sheath 62 and replacing it with a thin material along the length of the coaxial cable 36 or just at the balun 52 location. Increase. As will be described in more detail below, this added flexibility is more pronounced when the ablation catheter 14 is used in a luminal network having a bifurcated structure having a small diameter and having a plurality of sharp curves. It is advantageous to allow a large range of movement.

  The flexibility of the ablation catheter 14 can be varied to accommodate specific surgical procedures, specific luminal structures, specific target tissues, clinician preferences, and the like. For example, in one embodiment, it may be advantageous to have a very flexible ablation catheter 14 for movement through a relatively narrow airway in the patient's lungs. Alternatively, it may be advantageous to have an ablation catheter 14 that is only slightly flexible, for example when an ablation catheter 14 is required to puncture or puncture a target tissue. Still further, to achieve the desired amount of flexibility, the invention “Microwave Energy-Delivery Device and System,” the entire disclosure of which is incorporated herein by reference. It may be desirable to form the balun 52 consistent with the disclosure of U.S. Patent Application No. XX / XXX, XXX (Attorney Docket No. H-IL-00077 (1988-77)). Still further, even if the microwave ablation catheter described herein is specific, those skilled in the art have simplified or more complex structural details without departing from the scope of the present disclosure. It will be appreciated that other microwave ablation catheter embodiments may be used.

  In an embodiment, temperature monitoring system 3 (FIG. 1) (eg, microwave temperature measurement) may be utilized with ablation catheter 14 to observe / monitor the temperature of tissue in or adjacent to the ablation area. In one embodiment, for example, one or more temperature sensors “TS” may be provided on the ablation catheter 14 (shown in FIG. 5), for example, adjacent to the distal radiating portion 42 and within the ablation area. Or it may be configured to measure the temperature of the tissue adjacent thereto. The temperature monitoring system 3 may be, for example, a radiation measurement system, a thermocouple system, or any other tissue temperature monitoring system known in the art. The temperature monitoring system 3 may be incorporated into the energy source 16 to provide feedback to the energy source, or alternatively, a separate box that provides audible or visual feedback to the clinician during use of the ablation catheter 14. It may be accommodated in. In any embodiment, the temperature monitoring system 3 may be configured to provide tissue temperature and ablation zone temperature information to the energy source 16 (or other suitable control system). In embodiments, the temperature sensor 3 may be along the coaxial cable 36 or along the assembly 12 (see FIG. 1) to obtain more temperature data collection points and finer details regarding the tissue temperature after irradiation of energy. Or may be provided along the elongate working channel 90.

  In at least one embodiment, tissue temperature and / or ablation zone temperature information is collected by empirical testing and stored in one or more data look-up tables, and temperature detection monitoring system 3 and / or energy source 16 It may be correlated with the size or configuration of a particular known ablation area stored in the memory. The data look-up table may be accessible by the temperature detection monitoring system 3 and / or the processor of the energy source 16 and by the processor while supplying energy to the distal radiating portion 42 to treat the target tissue. May be accessed. In this embodiment, the temperature sensor “TS” provides the tissue temperature and / or ablation zone temperature to the microprocessor, which then stores the tissue temperature and / or ablation zone temperature in a data lookup table. Compare with the size of the known shochu area. The microprocessor may then send a command signal to the temperature detection monitoring system 3 and / or one or more modules of the energy source 16 to automatically adjust the microwave energy output to the distal radiating section 42. . Alternatively, a manual adjustment procedure may be utilized to control the microwave energy output to the distal radiating portion 42. In this embodiment, the microprocessor uses one or more instructions (eg, visual, audible and / or tactile instructions) when a particular tissue temperature and / or ablation area temperature matches the diameter or configuration of the corresponding ablation area. May be provided to the user.

  The system 10 shown in FIG. 1 is configured to treat tissue, and as further shown in FIG. 7, a computed tomography (CT) image is used to identify a target tissue (hereinafter simply referred to as “target”). Allows a method of identification and, once identified, further enables the use of a navigation or guidance system to place the catheter assembly 12 or other instrument at the target. CT data facilitates route planning to the identified target and allows the body to navigate to the target location, which is a pre-operative and intra-operative component (ie, route planning and route navigation). including.

  The path planning stage includes three general steps. In the first step, software is used to generate and display a three-dimensional model of the bronchial airway tree (“BT”) and to display CT data to identify the target. In the second step, software is used to select a route on the BT, if desired, automatically, semi-automatically or manually. In the third step, this path is automatically segmented into a set of waypoints along the path that can be visualized on the display. The airway is used herein as an example of a branch lumen network. Thus, the term “BT” is used in a generic sense to denote any such luminal network (eg, the circulatory system or gastrointestinal tract).

  The process of generating and displaying a BT using the software graphical interface 64 shown in FIG. 6 begins by importing a CT scan image of the patient's lungs into the software. The software processes the CT scan images, arranges these images in the order in which they were taken, and assembles them into a three-dimensional CT volume by separating them according to the CT settings when they were taken. The software uses the newly constructed CT volume to generate a three-dimensional map or BT of the airway. The software then displays a display of the three-dimensional map 66 on the software graphical interface 64. Various indications are presented to the user to identify the mass or tumor that the medical professional desires for a biopsy or treatment and that the medical professional desires to navigate to using the system 10 May be.

  The software then selects a path to the target (eg, target 68 identified by a medical professional). In one embodiment, the software includes an algorithm that performs path selection by starting with a selected target and following the lumen back to the entry point. The software then selects the location in the airway that is closest to the target. The airway diameter may be used to determine the route to the target.

  After the route is determined, or at the same time as the route is determined, the route indicated for reconsideration by the user is displayed. This pathway is the tracheal to target pathway determined by the software to be followed by a medical professional to treat the patient. This pathway may be accepted, rejected or modified by medical professionals. Used by system 10 to locate catheters and instruments for target biopsy and final treatment if necessary after identifying the path in BT associated with trachea in the CT image containing the target Export this route. A further method for determining a route from a CT image is described in the United States by the same applicant under the representative serial number H-IL-00087 (1988-00087) entitled "Pathway Planning System and Method". No. XX / XXX, XXX, the entire disclosure of which is incorporated herein by reference.

  FIG. 7 shows a patient “P” lying on the operating table 70 and connected to a system that allows navigation along a determined path in the lumen network to achieve access to the identified target. Is shown. A bronchoscope 72 has been inserted into the patient's lungs. The bronchoscope 72 is connected to a monitoring device 74 and typically includes a power source for lighting and video diagnostic imaging systems. In certain cases, the devices of the present disclosure may be used without a bronchoscope, as described below. System 10 monitors the position of patient “P” and thereby defines a set of reference coordinates. Specifically, system 10 is disclosed in US Pat. No. 6,188,355 and WO 00/10456 and WO 01/67035, the disclosures of which are incorporated herein by reference. A 6-degree-of-freedom electromagnetic position measurement system according to the teaching is used. Transmitter 76 is implemented as a plate or mat that is placed directly under patient “P”. A plurality of sensors 78 are interconnected with a tracking module 80 that derives the position of each sensor 78 in 6 DOF (degrees of freedom). One or more of the reference sensors 78 (eg, three sensors 78) are attached to the chest of the patient “P” and their 6DOF coordinates are sent to the computer 82 (including the software) where they are used. Calculate the patient coordinate reference system.

  FIG. 8 illustrates a positioning assembly 84 constructed and operated in accordance with the teachings of this disclosure. The positioning assembly 84 includes a steerable distal tip 88, an extensible working channel 90 and a positionable guide 86 having a control handle 92 at its proximal end.

  There are several ways to operate the extendable working channel 90. In the first method, a single deflection may be used. Alternatively, a multi-directional operation mechanism using a manual direction selection device may be used to enable selection of the operation direction by the practitioner without requiring rotation of the catheter body. For multidirectional operation, four elongate tension elements (“operation wires”) 98a are implemented as a pair of wires formed of a single long wire that extends from the handle 92 to the distal tip 88. The operation wire 98 a is bent on a part of the base portion 98 b and returned to the handle 92. Due to the individual tension on each wire, the manipulation wire 98a is deployed so that the distal tip 88 is manipulated in a predetermined lateral direction. In the case of the four operation wires 98a, the directions are selected so as to be in opposite directions along two vertical axes. In other words, when each wire is actuated alone, it causes a deflection of the distal tip 98 in a different one of four predetermined directions separated by a multiple of 90 ° substantially. Four operation wires 98a are developed.

  A positionable guide 86 is inserted into the elongate working channel 90 where it is secured in place by a securing mechanism 94. The position sensor element 96 of the system 10 is integrated with the distal tip 88 of the positionable guide 86 to allow monitoring of tip position and orientation (6 DOF) relative to a reference coordinate system.

  In an embodiment, the positionable guide 86 may have a curved or saddle-shaped configuration, as shown in FIG. This alternative is currently sold by Covidien under the name EDGE®. In such a system, it is the elongate working channel 90 that is formed with the curved tip 91. Different amounts of pre-bends mounted on the elongate working channel 90 can be used, but common curvatures include 45 °, 90 °, and 180 °. A working channel 90 extending at 180 ° has been found to be particularly useful to guide the positionable guide 86 to the posterior part of the upper lobe of the lung, which can be particularly difficult to navigate. A positionable guide 86 is inserted into the extendable working channel 90 such that the position sensor 96 protrudes from the distal tip 88 of the extendable working channel 90. The elongate working channel 90 and the positionable guide 86 are secured together so as to advance together within the lung passage of the patient “P”. In this embodiment, the extendable working channel 90 may include an operating mechanism similar to that already described above. As can be appreciated, certain modifications may have to be made to the extendable work channel 90 in order for the extendable work channel to function as intended.

  In an embodiment, an integrated radial ultrasound probe “US” (FIG. 10) is provided on the elongate working channel 90, the positionable guide 86, the catheter assembly 12 and / or the ablation catheter 14. Also good. For illustrative purposes, the ultrasound probe “US” is shown disposed on the extendable working channel 90 and the positionable guide 86. The ultrasound probe “US” provides ultrasonic feedback to one or more modules of the system 10 during navigation and insertion of the ablation catheter 14 to facilitate placement of the ablation catheter 14 adjacent to the target tissue. It may be configured to. Also, as will be appreciated, a US probe may be used with an endoscope for diagnostic imaging of central lesions without an extendable working channel but accessible by endoscope. In addition, a US probe may be used to monitor the progress of therapy and / or confirm the completion of therapy.

  As described above, the present disclosure uses CT data (images) for the path planning stage. CT data may also be used for the navigation stage. Specifically, the CT coordinate system is matched with the patient coordinate system. This is commonly known as registration. Registration is generally done by locating both the CT and body surface or in the body and measuring their coordinates in both systems. Manual, semi-automatic or automatic registration can be utilized in the system 10. For purposes herein, system 10 is described with respect to the use of automatic registration. For a more detailed description of the automatic registration technique, reference is made to commonly assigned US patent application Ser. No. 12 / 780,678, the disclosure of which is incorporated herein by reference.

  The automatic registration method includes moving a positionable guide 86 including a position sensor 96 within the bifurcation structure of patient “P”. The transmitter 80 is used to record data regarding the position of the position sensor 96 while the position sensor 96 is moving through the branch structure. The shape obtained from this data is compared with the internal shape of the passage of the three-dimensional model of the branch structure. Next, based on the comparison, a positional correlation between the shape and the three-dimensional model is determined.

  In addition to the above, the software of the system 10 identifies non-tissue spaces (eg, air filled cavities) in the 3D model. Thus, the software records the position data of the position sensor 96 of the positionable guide 86 as the positionable guide 86 is moving through one or more lumens of the bifurcated structure. Further, the software represents the position of the positionable guide 86 based on the recorded position data and the assumption that the positionable guide 86 remains positioned in the non-tissue space within the bifurcation structure. The image and the image of the three-dimensional model are arranged.

  When placed in the body of the patient “P”, a screen 93 is displayed on the monitoring device 74 by the software (FIG. 11). The right image is an actual bronchoscopic image 95 generated by the bronchoscope 72. Initially, no image is displayed in the left image 97, and when registration is completed, this becomes a virtual bronchoscopic image generated from CT image data.

  Starting with a position sensor 96, approximately 3-4 cm above the main tracheal bifurcation when viewed through the positionable guide 86, specifically the bronchoscope 72, the bronchoscope 72 is placed in the right and left lungs. Both, for example, advance through the passage of the fourth generation lung. Sufficient data is collected as described above so that registration can be achieved by traversing these areas of the lung.

  Once the target is identified, the path is planned, the bronchoscope 72 containing the positionable guide 86 is inserted into the patient “P”, and the virtual bronchoscope image is recorded along with the image data of the bronchoscope 72, the system 10 Will be ready to navigate the position sensor 96 to the target 68 in the patient's lungs. The computer 80 provides a display similar to that shown in FIG. 11, identifies the target 68 and shows a virtual bronchoscopic image 99. Appearing in each image on the display device is a path from the current position of the position sensor 96 to the target 68. This is the route established during the route planning phase. This path may be represented by a colored line, for example. Also appearing in each image is a display of the distal tip 88 of the positionable guide 86 and the position sensor 96. Once the path is established, the clinician can utilize the system 10 to treat the target tissue 68.

  The operation of the system 10 for treating the target tissue will be described with reference to FIGS. 12A-16C. Assume that the route to target 68 has been confirmed by the above method. After the bronchoscope 72 including the extendable working channel 90 and the positionable guide 86 is advanced to a pushable location in the lumen network, the extension work channel and the positionable guide are targeted along the specified path. Further advance to 68 (see FIGS. 12A-12C).

  In some cases, the target tissue may be accessed directly from within the lumen (eg, for treatment of the bronchial lining for chronic obstructive pulmonary disease (COPD), asthma, lung cancer, etc.), but in other examples, the target Is not in direct contact with the BT and access to the target is not achieved when the positionable guide is used alone. Additional access devices may be required across the lumen to access the target tissue (eg, for treatment of disease within the parenchyma).

  Final localization and confirmation of a positionable guide or access device including an extensible working channel is based on diagnostic imaging and / or navigation guidance, including the same or different combinations of diagnostic imaging and navigation techniques listed above. You may go.

  Once the positionable guide 86 or additional access device has been successfully navigated to the target 68 position, the positionable guide 86 or access instrument is removed and the elongate working channel 90 is moved to the target 68 position for the biopsy instrument 84. You may leave it arrange | positioned as a guide channel (FIG. 13A-FIG. 13B). The medical instrument may be a biopsy instrument that can be used for sampling the target 68. Details of this system are contained in US Pat. No. 7,233,820, which is already incorporated herein by reference.

  Once the positionable guide 86 has been successfully navigated to the target 68 position, the positionable guide 86 may be removed and the elongate working channel 90 may be left in place as a guide channel for carrying the instrument 84 to the target 68 position. (FIGS. 13A-13B). The medical instrument may be a biopsy instrument that can be used for sampling the target 68. These samples are collected and sent to the pathology for analysis to determine if target treatment is needed. The biopsy analysis may be performed in real time after the biopsy procedure so that ablation can be performed immediately, or some period of time between the time of performing the biopsy and the time of performing the ablation procedure (eg, (Hours, days, weeks) may be provided.

  If it is determined that the target 68 requires treatment (eg, ablation), the assembly 12 including the ablation catheter 14 may be placed through the bronchoscope 72 and the elongated working channel 90 to allow treatment. Placement of the assembly may occur after navigating the elongate working channel 90 to the target 68, or the elongate working channel 90 may be navigated with the assembly 12 to reach the target 68. This second option may require a 6 DOF positioning sensor in either the elongate working channel 90 or the assembly 12. As described above, the braided configuration of the outer conductor 48 and the conductive layer 51 of the balun 52 in combination with the lumen configuration shown in FIGS. 2 to 3 provides the flexibility necessary to move within a relatively narrow airway. 12 is obtained.

  In embodiments, the target tissue “T” may be punctured or penetrated to allow placement of the distal radiating portion 42 within the target 68 (eg, placement in the center of the mass for treatment). For example, the guide wire, puncture device, biopsy device 84 or the distal end 21 of the assembly 12 (described with reference to FIG. 1) may be utilized to puncture or penetrate the target 68. In examples where a guidewire or puncture device is used to penetrate or puncture tissue, the guidewire or puncture device may be passed through the elongate working channel 90 and through the target 68. Once punctured, the elongate working channel 90 is held in place, the guidewire or puncture instrument is removed, and the assembly 12 containing the ablation catheter 14 is placed in the opening in the target 68 created by the instrument or guidewire. It may be possible to insert in Alternatively, the elongate working channel 90 is extended while the guidewire or puncture device is in the target 68 and the distal end of the elongate working channel 90 is placed in the opening created in the target 68. May be. After the elongate working channel 90 is positioned within the target 68, the guidewire or puncture device may be removed to allow insertion of the assembly 12 including the ablation catheter 14. This second method ensures proper placement of the ablation catheter 14 contained within the assembly 12 within the target 68.

  One or more medical diagnostic imaging devices may be utilized to verify that the ablation catheter 14 is properly positioned (eg, within the target 68). For example, computed tomography (CT), ultrasound, fluoroscopy and other medical diagnostic imaging devices can be used individually or in combination with each other to verify that the ablation catheter 14 is properly positioned within the target 68. Also good. One method using both CT and fluoroscopy apparatus is described in commonly assigned US application Ser. No. 12 / 056,123 entitled “CT-Enhanced Fluoroscopy”. The disclosure of which is incorporated herein by reference.

  Yet another method of confirming the placement of the ablation catheter 14 is disclosed herein. FIG. 46A is a live fluorescence showing the placement of the elongate working channel 90 and the ablation assembly 12 or biopsy instrument 84 extending therefrom after performing one of the navigation procedures described herein. It is a fluoroscopic image. FIG. 46B is a virtual fluoroscopic image showing the same patient and displaying the target 68 on the body. The virtual fluoroscopic image is generated from the same CT data used in both the planning and navigation methods. The CT data is processed to create a computer model of the patient's fluoroscopic image. The target 68 is the same target 68 identified in the planning phase, and the target 68 position in the virtual fluoroscopic image corresponds to the target position identified by the clinician during planning.

  A virtual fluoroscopic image and a live fluoroscopic image may be registered for each other. For example, use one or more fiducial markers that are placed in front of the CT scan and also appear on fluoroscopic images, or identify intra-physiological landmarks (eg, ribcage curvature and spacing) that can function as fiducial markers This may be done by doing so. Two images, a live fluoroscopic image and a static virtual fluoroscopic image, allow the clinician to compare the placement of the elongate working channel 90 and the ablation assembly 12 with the target 68 position. This may be done in the control comparison mode shown in either FIG. 46A or 46B. For example, in FIG. 46A, a live fluoroscopic image, the mass 67 identified as the target 68 during the planning phase may be only slightly visible by fluoroscopy (it is not possible to identify soft tissue in the fluoroscopic image. Often difficult), comparing the position of the elongate working channel 90 and cautery assembly 12 shown in FIG. 46A with the target 68 position shown in FIG. 46B makes it easy to see the adjustments necessary for proper cautery placement can do.

  Alternatively, when registering live and virtual fluoroscopic images relative to each other, the virtual image (FIG. 46B) can be superimposed on the live image (FIG. 46A) and compared so that a composite image is generated. Good. The composite image then shows the relative position of the target 68 relative to the placement of the cautery assembly 12 and the elongate working channel 90. Continuing live fluoroscopy allows visualization of the placement of the elongate working channel 90 and / or the ablation assembly 12 or biopsy instrument 84 within the target 68, thus enabling the clinician to perform live fluorescence. Using the combination of the fluoroscopic image and the virtual fluoroscopic image superimposed, the proper placement in the target 68 can actually be seen in real time. Once the placement of the ablation catheter 14 within the target 68 is confirmed, microwave energy can be transmitted to the ablation catheter 14 to treat the target 68.

  After treatment of the target 68, use one of the medical diagnostic imaging devices to determine if a suitable ablation zone is formed around the target 68 and whether further energy irradiation is required You may decide. These treatment and imaging processes may be repeated iteratively until a determination is made that the target has been successfully cauterized. Further, the above method using the medical image diagnostic apparatus for confirming the degree of treatment and determining whether or not further energy irradiation is necessary is combined with the above radiometric and temperature detection techniques to obtain a medical image diagnostic apparatus. As well as helping to determine when to stop treatment.

  For example, in one embodiment where the target 68 is relatively close to the distal end of the bronchoscope 72, the elongate working channel 90 is removed (FIG. 14) or not used at all and the bronchoscope 72 is In place, the assembly 12 including the access device and the ablation catheter 14 may be visually guided to the target 68. Alternatively, the elongate working channel 90 and associated access device can be placed without using the bronchoscope 72, or the bronchoscope 72 can be removed after placement of the elongate working channel 90 in combination with the access device to the target 68. They can be left in place and the assembly 12 including the ablation catheter 14 can be extended from the elongate working channel 90 to treat the target 68.

  As described above, the temperature monitoring system 3 can be used to determine and monitor the temperature of the target tissue 68, the size of the ablation area, and the like. In an embodiment, the temperature monitoring system 3 may be incorporated into one or more components (eg, software graphical interface 64) configured for use with the system 10.

  In embodiments, placement of the elongate working channel 90 and / or the ablation catheter 14 within the luminal network may be accomplished without using the route planning and route navigation methods described above. In this case, computed tomography, ultrasound and / or fluoroscopy may be utilized to facilitate placement of the elongate working channel 90 and / or access device and / or ablation catheter 14 within the luminal network. .

  In an embodiment, the distal radiating portion 42 may be covered with a temperature sensitive “wax” material “W” that melts when energy is applied to the inner conductor 20, thereby changing the phase and causing distal radiating. The heat from the part 42 is absorbed.

  Further, instead of fluid cooling, the distal radiating portion 42 may be frozen to form ice around it. When energy is supplied to the distal radiant portion, this ice becomes a gas, which can result in high heat dissipation and then the distal radiant portion 42 is cooled.

  Further, in accordance with the present disclosure, it may be advantageous to utilize an ablation catheter 14 without the assembly 12. In this particular embodiment, the elongate working channel 90 (eg, one of the lumen and port configurations and the closed distal tip) may be modified to fluidly cool the ablation catheter 14. Also, as can be appreciated, one or more other modifications may have to be made to the elongate working channel 90 in order for it to function as intended herein. .

  15A-15B show an elongate working channel 190 having a closed distal end and a modified catheter assembly 12 inserted therein. Rather than the closed distal end shown in FIG. 1, the catheter assembly 12 has an open distal end. The space between the inner surface of the elongate working channel 190 and the catheter assembly 12 establishes a fluid inflow lumen 119a. The fluid outflow lumen 119 c is exposed by an opening at the distal end of the catheter assembly 12. Lumens 119a and 119c allow cooling fluid to flow through elongate working channel 190 and catheter assembly 12 to cool ablation catheter 14 located within catheter assembly 12. A cross-section of the elongate working channel 190 including the modified catheter assembly 12 is shown in FIG. 16D. The catheter assembly 12 may optionally include a position sensor 96 such that the catheter assembly 12 functions as a positionable guide 86 (FIG. 12) to assist in placing the elongate working channel on the target 68. The elongate working channel 190 may be formed so as to satisfy the above-described flexibility criterion. Alternatively, the elongate working channel may be positioned as described above using a positionable guide 86. Thereafter, the positionable guide 86 may be removed and the elongate working channel 190 may be left in place. With the positionable guide 86 removed, the modified catheter assembly 12 and ablation catheter 14 are placed in the elongate working channel 190 (FIG. 16A) and energized to be suitable for treating the target 68. An ablation zone “AB” may be formed (FIG. 16B). FIG. 16C illustrates yet another optional configuration in which the ablation catheter 14 is positioned within the elongate working channel 190 without assembly after placement of the elongate working channel 190 and removal of the positionable guide 86. Water may be circulated through the elongate working channel 190 to cool the distal radiant portion as described above.

  As can be appreciated, when the flexible assembly 12 including the ablation catheter 14 is inserted into the bronchus, navigating through the luminal bifurcation of the lung greatly reduces the likelihood of pneumothorax. Further, since the system 10 can generate a path to the target tissue, the placement of the assembly 12 including the positionable guide, the extensible working channel and the ablation catheter 14 is inferred.

  From the foregoing and with reference to the various drawings, those skilled in the art will also appreciate that certain modifications can be made to the present disclosure without departing from the scope of the invention. For example, one or more modifications can be made with respect to device delivery and placement, device cooling and antenna cushioning and sensor feedback. The following are various non-limiting examples of such modifications that are contemplated within the scope of this disclosure.

I. Device Delivery and Placement In accordance with the present disclosure, various methods can be utilized to deliver the ablation catheter 14 and / or the elongate working channel 90/190 to a desired location within the target tissue 68.

  For example, a bronchoscope may be used to form an embolus to deal with bleeding that occurs in the patient's body due to biopsy or cauterization. That is, the bronchoscope can be pushed into the bronchus and bleeding can be stopped where the bronchoscope can reach. However, according to the present disclosure, the elongate working channel 90/190 can be navigated to the target 68 to form an embolus and one or more expandable members are on the elongate working channel 90/190. It may be provided. An expandable member (eg, a balloon) can be inflated to stop bleeding at these remote locations.

  Specifically, FIGS. 17 and 18 show an elongate working channel 90/190 that includes a balloon “B” disposed on the outer surface of the elongate working channel 90/190. Balloon “B” is initially in a deflated configuration (FIG. 17) to navigate the elongate working channel 90/190 through the guide airway and position the elongate working channel 90/190 adjacent to the target 68. is there. The balloon is then inflated to secure the elongate working channel 90/190 in place and form an embolus (FIG. 18).

  In embodiments where the balloon “B” is provided on the elongate working channel 90, one or more lumens may be provided on the elongate working channel 90 and the balloon “B” from the fluid source 32 may be provided. May be supplied with one or more suitable fluids to be in fluid communication with the balloon “B” to move the balloon “B” from the inflated configuration to the deflated configuration (and vice versa). Further, in this embodiment, the balloon “B” may be configured to control local lung characteristics that change with respiration. For example, the relative permittivity at 2450 MHz of contracted lung tissue is 48, and the relative permittivity at the same frequency of expanded lung tissue is 20, and this large permittivity range allows the antenna to operate at a single frequency. It becomes difficult to adjust to. Empirical testing has shown that adding a balloon “B” locally separates the lungs during dilatation or deflation to provide one or more desired properties, eg, electrical and thermal properties I understood that. Specifically, thermal conductivity changes with lung expansion and contraction. For example, if local breathing is stopped by an expanded lung and the ablation catheter 14 is matched to a target 68 having a dielectric constant of 45, heating can be focused thermally and electrically on the target 68. . Similarly, if the lung is fixed in a contracted configuration, more lung tissue can be treated with heat to create additional margin around the target 68.

  19A-19B illustrate an ablation catheter 214 according to another embodiment of the present disclosure. The ablation catheter 214 is similar to the ablation catheter 14. Therefore, only those features specific to the ablation catheter 214 will be described in detail. An expandable balun 252 is provided on the coaxial cable 236. Balun 252 functions as described above with respect to balun 52. However, unlike balun 52, balun 252 is expandable (air / fluid pressure) and is configured to provide the function of balloon “B” as described above.

  One or more lumens (not shown) are provided in the ablation catheter 214 and receive one or more suitable fluids from the fluid source 32 for moving the balun 252 between the contracted and expanded configurations. (Refer FIG. 19A-FIG. 19B). Alternatively, the lumens 19a, 19c of the assembly 12 are in fluid communication with the balun 252 and one or more suitable fluids for displacing the balun 252 between the expanded and deflated configurations from the fluid source 32. 252 may be configured to supply. As can be appreciated, other methods and / or devices may be utilized to move the balun 252 between the expanded and deflated configurations.

  FIG. 20 illustrates an elongate working channel 290 according to another embodiment of the present disclosure. In this embodiment, the closed distal tip 291 can be energized to penetrate tissue “T”. Specifically, electrode 292 may be connected to distal tip 291 of elongate working channel 290. The electrode 291 may be in electrical communication with the energy source 16 via one or more leads or wires 293 that extend into the elongate working channel 290. The electrode 292 may be configured for unipolar operation. A return pad (not shown) may be disposed on the patient's body surface and used as a counter electrode plate. Alternatively, a second electrode (not shown) can be provided on the elongate working channel 290 to build a bipolar electrode configuration. In use, when the electrode 291 is energized, the distal tip 291 may be used to penetrate the tissue to facilitate positioning the elongate working channel 290 adjacent to the target tissue.

  FIG. 21 illustrates an elongate working channel 390 according to another embodiment of the present disclosure. The elongate working channel 390 includes a piston 325 that includes a closed distal end and a needle 325 extending through the base 323 and an opening (not shown) at the distal end of the lumen 319a distally from the base. And at least one water-filled lumen or chamber (eg, a cooling water loop lumen 319a utilized to cool the distal radiating portion 42) with 321. In order to maintain the pressure in the lumen, a seal (not shown) may be provided in the opening of the lumen 319a. An optional seal 327 is provided at the distal tip of the elongate working channel 390 and may be configured to maintain a fluid tight seal. The piston assembly 321 is movable within the lumen 319a to move the needle 325 from the retracted configuration through the seal 327 to the extended configuration (shown in the perspective view of FIG. 21). In the extended configuration, the needle 325 may be utilized to secure the extendable working channel 390 to the tissue and / or penetrate the tissue.

  In use, water may be supplied to the elongate working channel 390 to move the needle 325 to the extended configuration for penetrating tissue, prior to supplying energy to the distal radiating portion 42 and / or You may perform when energy is supplied to the distal radiation | emission part 42. FIG. In this way, the cooling water loop serves two purposes (cooling of the distal radiant portion and extension of the needle 325) and may eliminate the need for a separate push / pull member or sheath.

  FIG. 22 illustrates an elongate working channel 490 according to another embodiment of the present disclosure. The elongate working channel 490 includes an open distal end and an electrode 492 operably coupled thereto. The electrode 492 is similar to the electrode 292 illustrated in FIG. However, unlike the electrode 292, the electrode 492 may extend along the outer peripheral surface of the elongate working channel 490. In addition, a pair of upright electrode extensions 494a, 494b may be provided on the electrode 492 and configured to function as a monopolar pencil for treating tissue.

  The electrode 492 may be in electrical communication with the energy source 16 via one or more leads or wires 493 that extend into the elongate working channel 490. The electrode 492 may be configured for unipolar operation. A return pad (not shown) may be placed on the patient's body surface and used as a counter electrode. Alternatively, a second electrode (not shown) can be provided on the elongate working channel 490 to build a bipolar electrode configuration. In use, after cauterizing the tissue, upright extensions 494a, 494 may be utilized to transmit microwave energy (or RF) to adjacent tissue. After treating the tissue, the upright extensions 494a, 494b may be utilized to scrape the electrosurgically treated tissue. As can be appreciated, having the electrode 492 on the elongate working channel 490 allows the user to treat tissue with the electrode 492 while the ablation catheter 14 remains in the elongate working channel 490.

  FIG. 23 shows a head-up display device 81 (e.g., Google glasses) that communicates with the guidance system to provide the clinician with a virtual internal image. The virtual internal image contains information about planning the route to the target 68 and guidance and navigation information for one of the instrument, the extensible work channel and the positionable guide through the lungs of the patient “P”. Including. The head-up display 81 provides the position of the head-up display 81 relative to the patient “P” in order to project a virtual internal image in the proper orientation into the clinician's field of view where the patient “P” is visible 1 Two or more electromagnetic sensors 83 may be provided.

II. Device Cooling and Antenna Buffering The following embodiments are configured to protect the patient from unintentional heating by the coaxial cable 36 and / or the distal radiating portion 42 and / or are dielectric to the distal radiating portion 42. It is configured to give a buffer.

  24-26 illustrate an assembly 512 according to one embodiment of the present disclosure. The assembly 512 is similar to the assembly 12. Accordingly, only those features specific to assembly 512 will be described in detail.

  A partition 511 is provided in the housing 523 adjacent the distal end of the assembly 512 to provide a chamber 514 configured to separate the distal radiating portion 542 from the remainder of the coaxial cable 536. A dielectric (eg, ceramic, hydrogel, etc.) 513 is provided in the chamber 514 to cover the distal radiating portion 542 and communicates with the fluid that communicates through the lumens 519a, 519c and contacts the partition 511. In this case, the distal radiating portion 542 and the inner conductor 540 are configured to be cooled. In accordance with the present disclosure, the dielectric 513 can withstand heat without altering properties to buffer the distal radiating portion 542 and build a separate active cooling system around the coaxial cable 536. This can reduce phase changes around the distal radiating portion 542 during its operation, if not lost, and reduce the need for active cooling on the coaxial cable 536.

  FIG. 27 illustrates an assembly 612 according to one embodiment of the present disclosure. A plurality of ceramic elements 613 extend at least partially along the coaxial cable 636 and form a nested configuration. The ceramic element 613 functions as a heat sink for cooling the distal radiating portion 642 and the inner conductor 640. The ceramic element 613 increases cooling of the distal radiating portion 642 and the inner conductor 640 from a relaxed configuration (shown in FIG. 27) in which a plurality of ceramic elements 613 are spaced from one another so that the coaxial cable 636 can be bent. And may be operable to move to a compression configuration that moves the ceramic elements 613 towards each other to ensure positioning of the position of the assembly. A pair of puller wires 617 are operably coupled to the ceramic element 613 and are configured to move the ceramic element 613 to a compressed configuration.

  FIG. 28 illustrates an elongate working channel 790 according to one embodiment of the present disclosure. The elongate working channel 790 functions as a structural heat sink that is configured to dissipate heat alone or with a cooling fluid. In the embodiment shown in FIG. 28, the elongate working channel 790 is formed of a material that is a good thermal conductor for drawing heat away from the distal radiant portion 742. A heat sink 791 is operably coupled to the proximal end 793 of the elongate working channel 790. For example, lumens 719a, 719c (shown in perspective) extend to the proximal end of balun 752 to cool proximal end 793 of elongate working channel 790. In this particular embodiment, fluid flows to the proximal end of the balun 752 and makes a U-turn, thereby maintaining the elongate working channel 790 at the proximal end 793 cold. Utilizing conduction, cool air passes through the distal end of working channel 790 extending distally of balun 752 to the cooled proximal end 793 of elongate working channel 790 proximal of balun 752. Move. Additionally or alternatively, the ceramic paste “CP” may at least partially cover the distal radiating portion 742 and may function as a dielectric buffer for providing static cooling of the distal radiating portion 742. Good. The use of the ceramic paste “CP” may allow the elongate working channel 790 to be formed without the lumens 719a, 719c, and then elongate while providing static cooling and / or cushioning. The working channel 790 can remain flexible.

  FIG. 29 illustrates an elongate working channel 890 according to one embodiment of the present disclosure. A vacuum pump can be used to depressurize the water passing through the extendable work channel 890 and lower the boiling point of the water circulating through the extendable work channel 890. At this pressure, the water boils at about body temperature, the boiling water evaporates rapidly, and the phase change cools the fluid and its adjacent components, creating a further cooling effect on the ablation catheter 814. For this purpose, vacuum pump 33 is operably coupled to a fluid return port (not shown) on the elongate working channel to reduce the boiling point of the fluid circulating through lumen 819c. For this purpose, the fluid circulating through the lumen 819c is pressurized. In an embodiment, the air / mist mixture may be utilized as a cooling medium and circulated through the lumens 819a, 819c, and this embodiment can be used from a liquid even when the temperature remains constant. Utilizes the large energy required to change phase to steam.

  FIG. 30 shows an extendable working channel 990. The elongate working channel 990 may include two lumen configurations (not explicitly shown). In this embodiment, one lumen is dedicated to communication with a fluid suction port (not shown) of the elongate working channel 990 and one lumen is dedicated to supporting the ablation catheter 914. Unlike the previously disclosed lumen configuration, the fluid inlet port and lumen are configured for an open loop cooling protocol. An open loop cooling protocol may increase the flow of fluid in the elongate working channel 990. In addition, the target may be hydrated to enhance energy delivery and microwave energy absorption. Further, the open loop cooling protocol may be combined with the expandable balloon “B” and / or the expandable balun 252 to secure the elongate working channel 990 in place, which in turn allows the distal radiating portion 942 to be fixed. The dielectric buffer around may be increased.

  In an embodiment, the elongate working channel 990 includes a fluid return port and a corresponding third lumen configured to provide suction to expel cooling fluid dispensed from the elongate working channel 990. This allows the user to perform bronchoalveolar lavage (BAL) at the end of the microwave ablation procedure, i.e. stop the flow of fluid and aspirate the fluid back to one or more tissue samples. Can be recovered.

  31-32 illustrate an elongate working channel 1090 according to another embodiment of the present disclosure. In this embodiment, the distal radiating portion 1042 extends through a seal structure 1091 provided at the distal end of the elongate working channel 1090, thereby making the elongate working channel 1090 a thermal and electrical control means. May be used. Seal structure 1091 is configured to sealingly engage distal radiant portion 1042 to maintain a fluid tight seal when distal radiant portion 1042 is extended therethrough to treat tissue. Has been.

  FIG. 33 illustrates an elongate working channel 1190 according to another embodiment of the present disclosure. In this embodiment, the distal radiating portion 1142 is cooled without using the fluid flow buffer. With this purpose in mind, chamber 1191 is provided at the distal end of elongate working channel 1190 and is not in fluid communication with lumens 1119a, 1119c. Chamber 1191 surrounds distal radiant portion 1142 and is configured to receive a high boiling liquid (eg, water, saline, etc.) present therein to cool distal radiant portion 1142. . In this embodiment, seal members 1121a, 1121b may optionally be provided at the distal ends of the lumens 1119a, 1119c and are configured to maintain a high boiling point liquid in the chamber 1191. The higher boiling point liquid in chamber 1191 absorbs the heat generated by distal radiant portion 1142 and carries the heat to the fluid circulated through lumens 1119a and 1119c.

  34 and 35 illustrate an elongate working channel 1290 according to another embodiment of the present disclosure. In this embodiment, a heat sink 1291 having an accordion configuration is coupled to the distal end of the extensible working channel 1290. The heat sink 1291 is configured to couple to the distal radiant portion 1242 by one or more suitable coupling methods when the distal radiant portion 1242 is extended through the elongate working channel 1290. In the illustrated embodiment, the distal end of the elongate working channel 1290 may be provided, for example, with a seal (not shown), and as the distal radiating portion extends from the elongate working channel 1290, the distal radiation It may be configured to detachably engage with the part 1242 (by press fitting or friction fitting) (FIG. 34). As the heat sink heats, it begins to extend distally away from the elongate working channel 1290 and contacts a distal radiant portion 1242 coupled thereto. In the extended configuration, the distal radiating portion 1242 may have moved away from the surrounding tissue, which in turn may reduce incidental damage to the surrounding tissue (FIG. 35).

  36A and 36B show an ablation catheter 1314 according to one embodiment of the present disclosure. In the embodiment shown in FIGS. 36A and 36B, the heat sink is formed by a lung wall (“LW”), which typically includes a temperature of about 37 ° C. For this purpose, a thermally conductive balloon 1321 is placed adjacent to the distal radiant portion (not explicitly shown) of the ablation catheter 1314 to transfer heat from the distal radiant portion of the patient's lungs. Expandable (by one or more of the above lumen configurations) for dissipating into the wall “LW”. Specifically, when energy is supplied to the distal radiant portion, the thermally conductive balloon 1321 expands and expands to contact the lung wall “LW”, which in turn causes the thermally conductive balloon 1321 to Dissipates absorbed heat.

  Alternatively, a plurality of thermally conductive fins 1323 (FIGS. 37A-37B) may be disposed adjacent to the distal radiating portion. In this embodiment, the fins 1323 can be deployed to absorb and dissipate heat from the distal radiating portion when energy is supplied to the distal radiating portion. In the embodiment shown in FIGS. 37A-37B, the fins 1323 are formed of a shape memory metal configured to move to a deployed configuration when energy is supplied to the distal radiant section and heated. Upon deployment, an air flow may be introduced into the bronchi across the plurality of thermally conductive fins 1323 to cool the conductive fins 1323, which in turn cools the distal radiant portion.

  FIG. 38 illustrates an elongate working channel 1490 according to one embodiment of the present disclosure. In this embodiment, elongate working channel 1490 includes a proximal end 1491 having a larger diameter “D1” than a tapered distal end 1492 having a diameter “D2”. The larger diameter D1 of the proximal end 1491 allows more cooling for a given length of the elongate working channel 1490. According to the present disclosure, the diameter “D1” of the proximal end 1491 must be large enough to minimize pressure drop due to the coolant, but small enough to fit the airway.

  39A-39B illustrate an ablation catheter 1514 according to one embodiment of the present disclosure. Specifically, a balloon 1515 may be disposed adjacent to the radiating portion 1542 (and / or a balun (not shown)), and a lumen (not explicitly shown) within the ablation catheter 1514. It may be in fluid communication. Balloon 1515 is movable from a contracted configuration (FIG. 39A) to expand ablation catheter 1514 through an extendable working channel 1590 (FIG. 39A). In the inflated configuration, the balloon 1515 may function to expand the buffer volume, i.e., there is more volume to heat. Further, the balloon 1515 may be configured to secure the distal radiating portion 1542 within the lung airway. Further, the balloon 1515 may be configured to increase the flow rate around the balun of the ablation catheter 1514.

III. Sensor Feedback The following embodiments relate to the placement of devices (eg, elongate working channel 90/190, catheter assembly 12 and / or ablation catheter 14), tissue environment, ablation progression, device performance, safety, etc. It is configured to provide sensor and / or visual feedback to the system 10 or physician.

  According to the present disclosure, one or more feedback mechanisms can be utilized with the present disclosure. For example, FIGS. 40A-40B illustrate various fiducial markers that may be detectable by the system 10. Any of the above elongate working channels including an open distal end (eg, working channel 90) is utilized as a conduit for placing one or more fiducial markers in the patient's body after removal of the positionable guide 86. May be. These markers are used for a variety of purposes, such as identifying tumors and lesions for follow-up analysis and monitoring, to identify the location where biopsy sampling was performed and for therapeutic applications The boundary or center of the tumor or lesion can be identified. Other uses within the scope of this disclosure will be appreciated by those skilled in the art.

  In an embodiment, the fiducial marker may be formed of a shape memory alloy “SM”. In the present embodiment, the reference marker “SM” is configured to change its shape when heated to a predetermined temperature. Additionally or alternatively, the fiducial marker may be formed of poloxamer “PM”. Poloxamers can be converted from a liquid to a solid using energy from the distal radiating portion (eg, distal radiating portion 42) of the ablation catheter. When placed in the body, the fiducial marker “PM” lowers body temperature, returns to fluid, and is dissolved in the bloodstream. In solid form, the fiducial marker “PM” may be visible by CT, ultrasound and other medical imaging devices to reveal a real-time increase in the ablation area “AZ”.

  FIG. 41 illustrates another feedback mechanism that can be utilized with the system 10. In this embodiment, it can be placed in one of the elongate working channels (eg, elongate working channel 90) to measure the temperature of the distal radiating portion (eg, distal radiating portion 42). And a guide wire 73 that can be deployed therefrom may be used. Guide wire 73 includes at least one thermocouple 75 at its distal end. The thermocouple 75 may be configured to collect temperature measurements when deployed from the extendable working channel. The thermocouple 75 may be in communication with the microcontroller of the energy source 16 to monitor the rate of temperature change of the distal radiant portion 42 or may surround the distal radiant portion 42 and analyze the rate of change. Can be correlated with the size of a particular shochu. In an embodiment, ablation catheter 14 may be deployed from elongate working channel 90 using guidewire 73.

  42-43 illustrate another feedback mechanism that can be utilized with the system 10. In the embodiment shown in FIG. 42, the system 10 can detect the placement of the ablation catheter 1642 in healthy tissue relative to the tumor tissue or when bleeding occurs along the ablation catheter 1642. With this purpose in mind, one or more electrodes 1641 (two electrodes 1641 shown in FIG. 42) are provided adjacent to the distal radiating portion 1642, before and during operation of the distal radiating portion 1642. Alternatively, it is configured to detect data relating to a later target tissue. Data about the tissue may include tissue electrical properties (eg, RF impedance).

  In an embodiment, the electrode 1641 can be utilized to collect dielectric constant measurements of surrounding tissue to ensure placement within the tumor tissue. The amount and type of buffering of the distal radiating portion 1642 affects how much the electrode 1641 can obtain these measurements. A controller 17 (or another system 23 such as a laptop) connected to the ablation catheter 1614 to collect and analyze data that is interpreted by the user using either RF or dielectric constant measurements. ) Is required. After analyzing the data, the control device 17 provides related information to the user, for example, by the display device 37.

  In an embodiment, the controller 17 may be configured to perform S-parameter (FIG. 43) analysis between the input and output ports of the microwave energy source. In this embodiment, S-parameter analysis is used to determine the ablation size “AZ”, control the operation of the energy source 16 and / or detect damage to the distal radiating portion 1642 in real time.

  In embodiments, one or more sensor configurations may be utilized with the system 10. For example, the hydration sensor “HS” (see, eg, FIG. 43) is used to measure tissue moisture at a distance from the distal radiating portion 42 to monitor the progress and / or completion of ablation. In this case, the elongated working channel 90 may be used to place “HS” at a predetermined location away from where the distal radiating portion 42 is located. As moisture is lost from the tissue, the sensor “HS” can track the rate of change and inform the user when the ablation is complete. Dielectric properties can be directly correlated with tissue hydration levels.

  Further, one or more fiber optic cables “FC” may be present through an elongate working channel 90 positioned adjacent to the target tissue to give the clinician a visual view of the target tissue. Alternatively, an optical fiber cable “FC” may be provided adjacent to the distal radiating portion 42 (see, for example, FIG. 5). In this embodiment, one or more lenses (not shown) are provided adjacent to the distal radiating portion 42 and may be coupled to the distal end of the fiber optic cable “FC”. Additionally, one or more force sensors “FS” are configured to provide feedback regarding the force applied by the distal radiating portion 42 to penetrate tissue. In this case, the force sensor “FS” may be operatively coupled adjacent to the distal radiating portion (see, eg, FIG. 5).

  In an embodiment, one or more chemical sensors “CS” may be configured to detect one or more chemicals in the tissue before, during, or after activation of the distal emitter 42 (eg, , See FIG. In this embodiment, the chemical sensor “CS” may be in operative communication with a microcontroller 17 that is configured to detect chemicals (eg, acids and proteins) associated with the target tissue. Detected chemicals may be stored in one or more data look-up tables (not shown) that correlate with the progression of thermal ablation and are accessible to the microcontroller 17.

  FIG. 44 illustrates an arrangement configuration method for various sensor configurations. Specifically, a sensor (for example, an acoustic, thermocouple, or electric sensor) may be deployed using another airway. In one particular embodiment, the ablation catheter 14 may be extended through the elongate working channel 90 and placed between two opposing sensors, eg, an acoustic sensor “AS” located in the opposing airways. Good. During operation of the distal radiating portion 42, a ping across the airway can be generated to measure tissue properties (eg, measure impedance, dielectric constant or temperature).

  FIG. 45 illustrates another feedback mechanism that can be utilized with the system 10. In this embodiment, two antennas for monitoring ablation (eg, procedure / integrity), namely sensor patch 1840 and distal radiating portion 1842 of ablation catheter 1814 (for clarity, an extensible working channel (Not shown in the figure). The sensor patch 1840 can be placed on the patient's body surface and is configured to calibrate the ablation catheter 1814 prior to treating the tissue and determine when the tissue has been properly cauterized. The sensor patch 1840 is in operative communication with the controller 17 that is configured to monitor the amount of received power by the sensor patch 1840 when energy is supplied to the distal radiating portion 1842. The graph shows the power received by sensor patch 1840 during both calibration (points A to B) and ablation cycle (points C to D). The calibration cycle is based on the transmission line. As ablation progresses, the transmission path between the distal radiating portion 1842 and the sensor patch 1840 becomes less loss due to dehydration caused by the increase in received power. The amount of increase in received power over calibration determines the integrity of the ablation. For example, a 1.5 cm ablation zone “AZ” increases the power to sensor patch 1840 by approximately 15%. In one embodiment, the microcontroller 17 automatically stops power to the ablation catheter 1814 when the power at the sensor patch 1840 reaches or exceeds the calibration level.

  While several embodiments of the present disclosure have been shown in the drawings, the present disclosure is as broad as allowed by the art and the specification is to be construed in a similar manner. The disclosure is not limited thereto. Therefore, the above description should not be construed as limiting the invention, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims (15)

  1. A microwave ablation system configured for use in a luminal network, the microwave ablation system comprising:
    A microwave energy source,
    An instrument for treating tissue;
    An elongate working channel configured to provide a passage for the instrument;
    A positionable guide that is movable through the elongate working channel and configured to navigate the elongate working channel until adjacent to a target;
    A piston including a needle operably coupled to at least one fluid port of the elongate working channel and extendable from a distal end of the elongate working channel to puncture tissue;
    Equipped with a,
    The instrument is
    A coaxial cable connected at its proximal end to a microwave energy source and connected at its distal end to a distal radiant section, the coaxial cable comprising an inner conductor and an outer conductor and a dielectric positioned therebetween The inner conductor extends distally beyond the outer conductor and is in sealing engagement with the distal radiating portion;
    A balun partially formed of a conductor electrically connected to an outer conductor of the coaxial cable and extending along at least a part of the coaxial cable, the conductor having a braided configuration. And a balun covered with at least one insulator;
    A microwave ablation catheter comprising:
    The distal end of the elongate working channel can be energized to penetrate the target tissue;
    The distal end of the elongate working channel comprises at least one electrode extending at least partially along an outer peripheral surface of the elongate working channel;
    The microwave ablation system, wherein the at least one electrode is operable in a monopolar mode of operation .
  2.   The microwave ablation system according to claim 1, further comprising a bronchoscope configured to receive the elongate working channel for providing access to the luminal network.
  3. The elongate working channel comprises a closed distal end and a multi-lumen configuration configured to receive the ablation catheter, the elongate working channel further comprising a hub at a proximal end thereof, the hub The microwave ablation according to claim 1 , comprising a fluid suction port and a fluid return port configured to allow coolant to flow in and out of the elongate working channel to cool the ablation catheter, respectively. system.
  4. An expandable member on an outer surface of the elongate working channel, wherein the expandable member is movable in an inflated state to form an embolus when the microwave ablation catheter is placed in the lumen network. The microwave ablation system according to claim 3 , further comprising an expandable member.
  5. The microwave ablation system according to claim 4 , wherein the expandable member is configured to control local characteristics of the luminal network.
  6. The expandable member secures the elongate working channel when the elongate working channel is placed in the lumen network so that the positionable guide or the microwave ablation catheter is within the elongate working channel. The microwave ablation system according to claim 4 , wherein the microwave ablation system is configured to prevent the elongate working channel from moving out of position as it moves.
  7. The microwave ablation system according to claim 4 , wherein the expandable member is in the form of a balloon.
  8. The balun, the microwave ablation catheter is moveable into an expanded state to form emboli when disposed within the tube腔網microwave ablation system according to claim 3 1.
  9. The balun is configured to fix the microwave ablation catheter when the microwave ablation catheter is placed in the lumen network and maintain the microwave ablation catheter in a relatively fixed configuration. The microwave ablation system according to claim 8 .
  10. One of the distal tip of the distal radiating section and the extendable working channel of the microwave ablation catheter can be selectively energized to penetrate tissue, a microwave according to claim 1 Shochu system.
  11. Wherein the distal radiating portion of the microwave ablation catheter, the microwave ablation catheter is covered by the configured temperature sensitive wax to melt upon actuation, microwave ablation system according to claim 1.
  12.   The navigation system for guiding at least one of the instrument, the elongate working channel or the positionable guide through the lumen network following a predetermined determined path. The microwave ablation system described in 1.
  13. The microwave ablation system according to claim 12 , wherein the predetermined path is generated based on computed tomography (CT) data of the luminal network and displayed in the generated model.
  14. The predetermined route identifies a route to a target identified by a user in the CT data, and generates the route to obtain user consent prior to use in the navigation system. The microwave ablation system according to claim 13 , wherein the microwave ablation system is generated from CT data.
  15. The microwave ablation system according to claim 14 , wherein the navigation system further comprises a head-up display device.
JP2015526564A 2012-08-07 2013-07-26 Microwave ablation catheter and method of using the same Active JP6416091B2 (en)

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US201261680555P true 2012-08-07 2012-08-07
US61/680,555 2012-08-07
US201361784297P true 2013-03-14 2013-03-14
US201361784048P true 2013-03-14 2013-03-14
US201361784176P true 2013-03-14 2013-03-14
US201361784407P true 2013-03-14 2013-03-14
US201361783921P true 2013-03-14 2013-03-14
US61/783,921 2013-03-14
US61/784,048 2013-03-14
US61/784,297 2013-03-14
US61/784,176 2013-03-14
US61/784,407 2013-03-14
PCT/US2013/052187 WO2014025551A1 (en) 2012-08-07 2013-07-26 Microwave ablation catheter and method of utilizing the same

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